NeuroField Analysis Suite

K240420 · Neurofield, Inc. · OLU · Sep 20, 2024 · Neurology

Device Facts

• Record ID: K240420
• Device Name: NeuroField Analysis Suite
• Applicant: Neurofield, Inc.
• Product Code: OLU · Neurology
• Decision Date: Sep 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The NeuroField Analysis Suite is to be used by qualified medical and qualified clinical professionals for the display and storage of electrical activity of a patient's brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and event-related potentials (ERP).

Device Story

NeuroField Analysis Suite is a software-as-a-medical-device (SaMD) for EEG and ERP analysis. It consists of two modules: NF EEG Analysis and NF ERP. The EEG module integrates with the Q21 EEG system to perform real-time/offline analysis, including re-montaging, filtering, and Z-score generation for power spectra and LORETA current densities. The ERP module controls stimulus presentation (auditory/visual), epoching, and averaging to measure evoked potential latency and magnitude. Used in clinical settings by qualified professionals, the software processes EEG data to assist in brain activity evaluation. Output is displayed via UI for clinician review, aiding in clinical decision-making by providing statistical insights into brain electrical activity. The device benefits patients by enabling standardized, quantitative assessment of EEG/ERP signals.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including comparative performance evaluations of EEG analysis against the NeuroGuide predicate and mathematical validation of ERP generation and reliability (split-half reliability) for the NF-ERP module.

Technological Characteristics

SaMD; Windows-based software. EEG analysis uses FFT spectrum, IIR/Notch filtering, and Key Institute 2394 Voxel LORETA model with Brodmann Atlas. ERP module supports auditory/visual oddball paradigms. Connectivity via USB-CAN interface. Supports EDF, EDF+, and XDF file formats. Operates on standard 10-20 system electrode placements (up to 38 channels).

Indications for Use

Indicated for patients of all ages for the display, storage, and post-hoc statistical evaluation of EEG and ERP data by qualified clinical professionals.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• NeuroGuide Analysis System (K041263)
• eVox System (K171781)

Submission Summary (Full Text)

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September 20, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services - USA. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.

NeuroField Inc. % Tom Renner Quality, Efficiency & Regulatory Affairs Consultant Vision28 915 SW Rimrock Way Ste 201 Pmb 402 Redmond, Oregon 97756

Re: K240420

Trade/Device Name: NeuroField Analysis Suite Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU, GWJ Dated: February 13, 2024 Received: February 13, 2024

Dear Tom Renner:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Image /page/2/Picture/3 description: The image shows the text "Patrick Antkowiak -S" to the right of the letters "FDA". The letters "FDA" are in a light blue color. The text "Patrick Antkowiak -S" is in black.

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K240420

Device Name NeuroField Analysis Suite

Indications for Use (Describe)

The NeuroField Analysis Suite is to be used by qualified clinical professionals for the display and storage of electrical activity of a patient's brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and event-related potentials (ERP).

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| <table><tr><td><div> <input checked="true" type="checkbox"/> Research Use (Per 21 CFR 201.26(a) and (b)) </div></td></tr><tr><td><div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 201.66) </div></td></tr></table> | <div> <input checked="true" type="checkbox"/> Research Use (Per 21 CFR 201.26(a) and (b)) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 201.66) </div> |
| <div> <input checked="true" type="checkbox"/> Research Use (Per 21 CFR 201.26(a) and (b)) </div> | | |
| <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 201.66) </div> | | |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

### Contact Details

| Applicant Name: | NeuroField Inc. |
|-----------------|--------------------------------------------------------|
| | 1836 State Street |
| | Santa Barbara, CA 93101 |
| Contact Name: | Tom Renner |
| | Quality, Efficiency & Regulatory Affairs Consultant |
| | Vision28 |
| | <a href="mailto:[e-mail]">[e-mail]</a> |
| | 541 359 5939 |
| Date Prepared: | September 19, 2023 |

#### Device Name

| Trade Name: | NeuroField Analysis Suite |
|---------------------------------|---------------------------|
| Product Code: | OLU, GWJ |
| Common and Classification Name: | Electroencephalograph |
| Classification Regulation: | 21 CFR 882.1400 |
| Product Class: | Class II |

#### Legally Marketed Predicate Device

| 510(k) | Product Code | Trade Name | Applicant |
|---------|--------------|-------------------------------|----------------------------------------------------------------------------------------|
| K041263 | OLU | NeuroGuide<br>Analysis System | Applied Neuroscience, Inc.<br>228 176th Terrace Drive<br>St. Petersburg, Florida 33708 |

#### Legally Marketed Secondary Predicate Device

| 510(k) | Product Code | Trade Name | Applicant |
|---------|--------------|-------------|----------------------------------------------------------------------------------------------|
| K171781 | GWJ | eVox System | Evoke Neuroscience, Inc.<br>200 Valencia Dr. Suite 109<br>Jacksonville, North Carolina 28546 |

### Device Description

### I. Overview

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The NeuroField Analysis Suite is a Normalizing Quantitative Electroencephalograph (QEEG) Software that can (1) execute EEG analysis and (2) conduct ERP test and ERP analysis. The NeuroField Analysis Suite is Software as a Medical Device (SaMD).

#### II. Major Components

The NeuroField Analysis Suite consists of two modules, the NF EEG Analysis Module and the NF ERP Module.

The NF EEG Analysis Module is a separate analysis module that integrates with the Q21 EEG system by adding "Analysis", "Report", and "Tools" menu items and toolbars. It performs real-time and offline analysis functions and displays analysis results in separate windows in the UI, which can be accessed via the "Analysis" and "Reports" menu items.

The NF ERP Module is a separate evoked response potential (ERP) module that can control and get data from the Q21 EEG system and performs typical ERP functions like stimulus presentation, EEG epoching, epoch averaging, reaction time, and ERP display. The NF ERP Module is a separate stand-alone application.

## Intended Use/Indications for use

The NeuroField Analysis Suite is to be used by qualified medical and qualified clinical professionals for the display and storage of electrical activity of a patient's brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and eventrelated potentials (ERP).

## Substantial Equivalence Comparison

Based upon comparisons of regulatory parameters, features, and performance evaluations, the NeuroField EEG Analysis module of the NeuroField Analysis Suite is substantially equivalent to the primary predicate device, NeuroGuide Analysis System (K041263), and the NeuroField ERP functions are substantially equivalent to the secondary predicate device, eVox System (K171781).

The comparison between the NeuroField Analysis Suite, the primary predicate NeuroGuide Analysis System (K041263) and the secondary predicate eVox System (K171781) below consists of a series of tables followed by explanations of the similarities and differences described in each table.

## III. Comparison of Regulatory Parameters

| Comparison | NeuroField Analysis Suite | Primary Predicate:<br>NeuroGuide Analysis<br>System (K041263) | Secondary Predicate:<br>eVox System (K171781) |
|------------|---------------------------|---------------------------------------------------------------|-----------------------------------------------|
|------------|---------------------------|---------------------------------------------------------------|-----------------------------------------------|

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| Indications<br>for use | The NeuroField Analysis<br>Suite is to be used by<br>qualified medical and<br>qualified clinical<br>professionals for the<br>display and storage of<br>electrical activity of a<br>patient's brain, including<br>the post-hoc statistical<br>evaluation of the human<br>electroencephalogram<br>(EEG) and event-related<br>potentials (ERP). | The NeuroGuide<br>Analysis system is to be<br>used by qualified<br>medical and qualified<br>clinical professionals for<br>the post-hoc statistical<br>evaluation of the<br>human<br>electroencephalogram<br>(EEG). | The eVox System is<br>intended for the<br>acquisition, display, and<br>storage, of electrical<br>activity of a patient's<br>brain including<br>electroencephalograph<br>(EEG) and event-related<br>potentials (ERP) obtained<br>by placing two or more<br>electrodes on the head<br>to aid in diagnosis. |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>population | Patients of all ages. | Patients of all ages (“2<br>months to 82 years”). | All age groups. |
| Common or<br>usual name | Normalizing Quantitative<br>Electroencephalograph<br>Software<br><br>Stimulator, Auditory,<br>Evoked Response | Normalizing Quantitative<br>Electroencephalograph<br>Software | Full Montage<br>Electroencephalograph<br><br>Stimulator, Auditory,<br>Evoked Response |
| Regulatory<br>Class | Class II | Class II | Class II |
| Classification<br>name and<br>product code | 882.1400<br>Electroencephalograph<br>OLU<br><br>882.1900 Evoked response<br>auditory stimulator GWJ | 882.1400<br>Electroencephalograph<br>OLU | 882.1400<br>Electroencephalograph<br>GWQ<br><br>882.1900 Evoked<br>response auditory<br>stimulator<br>GWJ |

### Discussion of Similarities and Differences

The NeuroField Analysis Suite and the primary predicate are materially the same in regulatory parameters:

- Both are Normalizing Quantitative Electroencephalograph Software that can be ● used with all ages of patients
- Both are for statistical evaluation of the human electroencephalogram (EEG)
- Both have the same classification name, primary product code, and regulatory class

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The Indications for Use of the NeuroField Analysis Suite consist of a combination of the Indications for use of the predicate ("The NeuroGuide Analysis system is to be used by qualified medical and qualified clinical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG).") and the relevant section of the Indications for Use of the secondary predicate ("display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP)".

The secondary predicate is provided because of its event-related potentials (ERP) features, compared below.

| IV. Comparison of Features – EEG Analysis (OLU) | | | |
|-------------------------------------------------|--------------------------------|---------------------------|------------------------------------------------------------|
| Category | Comparison | NeuroField Analysis Suite | Primary Predicate:<br>NeuroGuide Analysis System (K041263) |
| General | Default File Format | Proprietary nfx format | Proprietary ng format |
| | Supported Open File Standards | EDF, EDF+, XDF | EDF, EDF+ |
| | Supported Device and Vendors | Neurofield Q21 | Neurofield Q21 and various other vendors |
| | Re-montaging | Yes | Yes |
| | IIR Filtering | Yes | Yes |
| | Notch Filtering | Yes | Yes |
| | Add Event Markers | Yes | Yes |
| | Analyze Whole Data | Yes | Yes |
| | Analyze Selected Interval | Yes | Yes |
| | Analyze Selected Markers only | Yes | No |
| Power<br>Analysis | Absolute Power<br>Raw/Z-Scores | Yes | Yes |
| | Relative Power Raw / Z-Scores | Yes | Yes |
| | Power Ratios Raw / Z-Scores | Yes | Yes |
| | Head Maps | Yes | Yes |
| | FFT Spectrum | Yes | Yes |
| | Frequency<br>Resolution | 0.5 Hz | 0.5 Hz |
| | Single Frequency<br>Side-Lobe | < -60 dB | First Sidelobe at -45 dB |
| | Tabular Export or View | Yes | Yes |
| | Automated Report | Yes | Yes |

#### IV. Comparison of Features - EEG Analysis (OLU)

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| | Model | Key Institute 2394 Voxel LORETA Model | Key Institute 2394 Voxel LORETA Model |
|--------|-------------------------------|---------------------------------------|----------------------------------------|
| LORETA | Atlas | Brodmann | Brodmann |
| | 3-D Cortex View | Yes | Yes (through<br>NeuroNavigator Add-on) |
| | Current Density –<br>Raw | Yes | Yes |
| | Current Density – Z<br>Scores | No | Yes |
| | Absolute Power –<br>Raw | Yes | Yes |
| | Absolute Power – Z<br>Scores | No | Yes |
| | Coherence / Phase<br>Metrics | No | Yes |

#### Discussion of Similarities and Differences

The NeuroField Analysis Suite and the primary predicate are substantially equivalent with respect to the implementation of most standard Quantitative Electroencephalograph Software features, including:

- Both perform re-montaging, filtering, adding event markers, and analysis based upon markers or whole data.
- Both generate Z-Scores for absolute power and relative power of EEG bands or individual frequencies.
- Both generate head maps and FFT spectra, and with equivalent frequency resolution.
- Both provide for tabular export and automated report generation.
- Both can calculate the inverse solution (using the standard LORETA Key Institute 2394 LORETA model) and generate the current densities and powers of the ROIs (Region of Interest) over the cortex using the Brodmann Atlas.
- Both can read standard EDF and EDF+ files.

The two systems differ with respect to file format support and LORETA Z-scoring:

- The NeuroField Analysis Suite can read/export XDF files in addition to EDF / EDF+ . files.
- The predicate can read various proprietary EEG file formats from EEG amplifier vendors.
- . The predicate generates Z-Scores for the LORETA solution and calculates coherence and phase metrics between the regions.

These differences are minor, and do not materially affect their substantial equivalence with respect to technological basis or use.

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| Comparison | NeuroField Analysis Suite | Secondary Predicate:<br>eVox System (K171781) | Comment |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ERP Stimulus<br>Modality | Auditory; Visual | Auditory; Visual | |
| ERP<br>Paradigm<br>(Auditory<br>and<br>Visual<br>Stimuli) | P300 Oddball<br>- Single Stimulus<br>Simple Go/No-Go<br>Cued Go/No-Go<br>Active | P300 Oddball<br>- Single Stimulus<br>- Single Deviant<br>- 2 Deviant<br>- Active and Passive | |
| ERP Task<br>Response | Mouse click | User Buttons | |
| Number of<br>Signal<br>Recording<br>Channels | Up to 38 | Up to 21 | |
| Recording<br>Channels<br>Location<br>and<br>Positioning<br>Systems | Consistent with the 10-20<br>System | Fz, Cz, Pz, F3, P3, F4, P4<br>Utilizing elastic bands<br>using distance ratios<br>consistent with the 10-<br>20<br>System | |
| Impedance<br>Test | Yes | Yes | |
| Interface<br>with<br>Amplifier | USB-CAN | Class 2 Bluetooth<br>version<br>2.0 to PC | |
| Filtering | User Definable for Visual<br>inspection of the EEG in<br>the 0.1 – 128 Hz range.<br>The underlying software<br>always retains and saves<br>the unfiltered data so that<br>it can be visualized under<br>various filtering settings<br>during postprocessing. | 0.1 to 50 Hz | |
| Audio<br>Frequency<br>Range | 500 Hz, 1 kHz, user<br>definable. NF-ERP uses<br>the operating system<br>capabilities to generate<br>the audio. Therefore, the | 440Hz-16kHz | NF ERP module has<br>default 500 Hz and<br>1 kHz audio stims.<br>These stims can be<br>altered by the user |
| | clinician user can change | | The eVox system |
| | the stimulus waveform. | | generates a sound |
| | The default is: No-Go | | with a frequency |
| | Stimulus: 500 kHz, Go | | range of 440Hz- |
| | Stimulus: 1 kHz | | 16kHz which is a |
| | | | sufficiently wide |
| | | | enough band for |
| | | | human hearing. |
| Audio<br>Intensity | User computer volume<br>setting | 0 to 85dB | |
| Technological<br>Differences<br>in how users<br>administer<br>and set tasks<br>for evoked<br>response<br>stimulation | NF-ERP uses the computer<br>system clock, and the<br>microsecond time stamps<br>on the USB-CAN interface<br>to time lock (synchronize)<br>EEG data samples, stimuli<br>and the user responses.<br><br>NF-ERP uses computer<br>mouse to record user<br>responses. | Specific details of the<br>eVox system are<br>proprietary to the<br>manufacturer. Based on<br>the available data:<br>The eVox system, like<br>NF-ERP, uses custom<br>software specifically<br>designed to present<br>stimuli (auditory or<br>visual) to the patient.<br>The software controls<br>the timing of stimulus<br>presentation and sends<br>triggers to the EEG<br>acquisition system<br>ensuring millisecond<br>accuracy.<br><br>eVox system uses USB-<br>based triggering to<br>record user events<br>(response button) | Both systems use<br>similar<br>technologies for<br>time locking and<br>user events. |
| User-defined<br>Task<br>Parameters | - ERP Paradigm<br>(Visual or auditory)<br>– see above<br>- Active ERP (user<br>always responds<br>to the Go stimuli)<br>- Enable / Disable<br>Warning Stimulus<br>- Enable / disable<br>ripple effect on<br>the stimuli (for | - ERP Paradigm<br>(Visual or<br>auditory)- see<br>above<br>- Active or<br>Passive ERP<br>- Volume Setting | Both systems use<br>similar<br>technologies for<br>time locking and<br>user events. It is<br>not clear in the<br>eVox<br>documentation<br>whether it uses use<br>adjustable stimulus<br>period, number of |

#### V. Comparison of Features – ERP Analysis (GWJ)

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| Simple Go-No/Go paradigm)<br>- Stimulus period<br>(for oddball paradigm)<br>- Go stimulus probability<br>- Number of cycles<br>- Task page background color.<br>Volume Setting | cycles, or Go stimulus probability. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|

The NeuroField ERP module and the secondary predicate are substantially equivalent with respect to the implementation of most standard ERP features, including:

- Both generate averaged ERP graphs for the EEG channels, allowing the user to measure the latency and magnitude of the evoked potentials.
- . Both allow for customizable session length.
- Both apply the auditory and visual oddball paradigm, where the user is presented with a periodic common stimuli and the frequency or the duration (in the case of auditory stimulus) or the image (in the case of visual stimuli) is altered infrequently, making it the oddball.
- Both allow the user to set parameters for the visual and auditory oddball paradigm.

The two systems differ in a few ways:

- In the Neurofield ERP Module, the filtering is user definable, whereas in eVox system, it is fixed to a 0.1 - 50 Hz bandpass.
- . The Neurofield ERP module interface with the device is USB-CAN, whereas the eVox System uses Bluetooth.
- . The Neurofield ERP module uses standard 19-channels, whereas eVox uses only a subset of the standard (7 channels).

These differences are minor, and do not materially affect their substantial equivalence with respect to technological basis or use.

## VI. Comparative Performance Evaluations

NF EEG Analysis module and Neuroguide perform similar QEEG analysis on Eyes Closed and Eyes Open task recorded EEG data. Both programs generate Z-Scores for absolute power and relative power of EEG bands or individual frequencies. They can also calculate the inverse solution (using the standard LORETA Key Institute 2394 LORETA model) and generate the current densities and powers of the ROIs (Region of Interest) over the cortex using the Brodmann Atlas. They can read standard EDF and EDF+ files. NF EEG, like Neuroguide, can read/export EDF/EDF+ files. NF-EEG also has XDF file format support. On

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the other hand, Neuroguide can read various proprietary EEG file formats from EEG amplifier vendors.

Comparative performance evaluations showed that the same EDF file, loaded to NF-EEG and Neuroguide shows comparable signals on the EEG Plot. When the spectrums are calculated, the result from both programs shows comparable spectrum and sidelobes both for real and simulated data. Both programs show comparable Z-Scores. The visualization of headmaps in both programs also shows comparable topographies over the standard EEG bands. Therefore, NF-EEG demonstrates a comparable performance to the predicate device.

NF ERP Module and eVox System perform similar ERP recording and analysis. Both programs can generate averaged ERP graphs for the EEG channels, allowing the user to measure the latency and magnitude of the evoked potentials. Both programs apply variations of the oddball paradigm, where the user is presented with a periodic common stimulus and the frequency or the duration (in the case of auditory stimulus) or the image (in the case of visual stimuli) is altered infrequently, making it the oddball. In the Neurofield ERP Module, more parameters are user-definable, like the visual filtering, oddball period, Go probability. Clinician also can customize the audio or visual stims. Also, Neurofield ERP module uses 10-20 standard 19-channels or 38- channels, whereas eVox uses a subset of the standard (7 channels).

Since an ERP test requires perfect synchronization between the stimulus time recording and EEG data, comparative performance evaluations were not performed directly between the Neurofield ERP and eVox systems. Instead, a mathematical validation of NF-ERP was performed. This mathematical assessment shows that the generated averaged ERPs are mathematically correct. Moreover, the analysis of real data shows that the NF-ERP can elicit correct ERP components, the generated stimulus is reliable, and the split-half reliability measure confirms test reliability. As a result, the NF-ERP and eVox systems will both produce comparable, mathematically correct oddball ERPs, and the NF-ERP performs that task as well as the predicate device.

#### VII. Clinical Performance Evaluations

Clinical performance evaluations are not necessary to demonstrate substantial equivalence to the predicate device.

#### VIII. Conclusion

The devices have materially the same indications for use and the same classifications. They have most of the same features. They are used on the same populations. The two products are different in minor ways that do not materially affect their technological basis or use.

Based upon comparisons of regulatory parameters, features, and performance evaluations, the NeuroField Analysis Suite is substantially equivalent to the primary predicate device,

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NeuroGuide Analysis System (K041263), and the NeuroField ERP functions are substantially equivalent to the secondary predicate device, eVox System (K171781).